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Senior Quality Assurance Specialist
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Job Summary:
We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Resilience. As a key member of our quality control team, you will be responsible for ensuring the highest standards of quality in our biomanufacturing processes.
Key Responsibilities:
- Perform sample analysis using advanced bioanalytical techniques such as HPLC, UPLC, PCR, and ELISA, as per SOPs and protocols.
- Develop and execute QC studies and write comprehensive reports.
- Lead and execute instrument qualification work as required.
- Assist in method transfer and qualification activities.
- Respond to internal and external auditors on questions related to assays and instruments.
- Participate in scheduled cleaning and other laboratory housekeeping duties.
- Employ good documentation practices when generating raw data, reports, SOPs, and other documentation.
- Author lab investigations with supervisor.
- Report to supervisor any deviations from company procedures or other discrepancies that may affect product quality or cGMP status.
- Perform other routine testing after training to support analytical testing requirements in the lab.
- Ensure documentations are accurate and up to date.
- Assist in implementation of corrective action plans, participate in identifying root causes, and communicate with other departments regarding pending issues.
Requirements:
- Strong understanding of GMP, GLP, 21 CFR, ICH, Pharmacopeial, and Regulatory guidelines.
- Advanced knowledge and practical experience in protein analysis, including BCA, Western blot, SDS-PAGE, ELISA, concentration analysis using UV-Vis Spectrophotometer/Nephelometry/Cell culture testing, PCR, HPLC/UPLC.
- Data analysis, statistics, and report preparation with knowledge of MS Word, Excel, and Outlook.
- Strong attention to detail, self-motivated, highly organized, and able to work in a fast-paced laboratory environment.
- Able to multi-task and very flexible based on job priorities.
- Ability to learn new bioanalytical techniques quickly.
- Good verbal and written communication (technical writing/protocols/reports).
- Strong presentation skills.
- Strong instrument trouble shooting skills.
Preferred Qualifications:
- Bachelor's degree (Biochemistry/Biotechnology/Chemistry) with 7 years related experience within a quality lab environment (biologics pharmaceutical preferred) or Master's degree (Biochemistry/Biotechnology/Chemistry) with 5 years related experience within a quality lab environment (biologics pharmaceutical preferred).
- Very good knowledge in HPLC/UPLC/Plate reader/spectrophotometer.
- Advanced Bioanalytical instruments/HPLC/GC/Imager.
Additional Requirements:
- Pre-employment medical and medical re-examination; inclusive of eye examination and colour blindness test, performed every 2 years or as required.
- This position requires vaccination for Hepatitis A and B.
- Job requires shift work, weekends, and occasional extended shifts and possible short notice schedule shift changes.